Home NDC 0228-2129 Clonidine Hydrochloride
Product NDC 0228-2129
11-digit product format 002282129
Labeler code 0228
Product ID 0228-2129_860129c9-0bba-471e-a90c-b6bede1833b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clonidine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA070976
Marketing category ANDA
Marketing start 1995-01-03
Substance CLONIDINE HYDROCHLORIDE
Active strength .3 mg/1
Pharmacologic classes Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070976-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070976-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070976-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 1986-12-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clonidine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONIDINE HYDROCHLORIDE .3 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W76I6XXF06 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884173 Internal RxNorm lookup 884185 Internal RxNorm lookup 884189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0228-2129-10 Clonidine Hydrochloride 100 in 1 BOTTLE TABLET 100 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0228-2129 CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.] 17 Current NDC, Legacy NDC, 1 package rows 20231216_a842ab83-3531-44dd-a8a8-64dd89e87026.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0228-2129-10 00228212910 100 TABLET in 1 BOTTLE (0228-2129-10) 100 tablet 1995-01-03 0000-00-00 No No Current